Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:14 PM
Ignite Modification Date: 2025-12-25 @ 1:36 PM
NCT ID: NCT00118092
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00118092
Study Brief: 17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Tanespimycin) Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. None None 2 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Premature ventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Electrocardiogram QTc interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Body odor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View